On March 19, 2025, China’s National Medical Products Administration (NMPA) released draft measures and procedures for drug trial data protection, soliciting public opinions until May 18, 2025. The initiative aims to foster drug innovation and meet public medication needs, in line with relevant pharmaceutical regulations.<\/p>\n\n\n\n
Data Protection Framework<\/strong> Protection Periods by Drug Type<\/strong>
The draft measures define data protection as safeguarding trial data and other independently obtained, undisclosed information when approving drugs with new chemical components or other eligible criteria. The NMPA will grant a data protection period of up to six years, during which other applicants cannot use the protected data for marketing authorization or supplementary applications without the holder’s consent, except for those who have independently obtained the data.<\/p>\n\n\n\n
The NMPA has outlined varying data protection periods for different drug categories:<\/p>\n\n\n\n